GlaxoSmith Hiring Clinical Dictionaries Analyst Bachelors or equivalent Science, Life Science, Nursing, Pharmacy Apply Now
This
role will provide YOU the opportunity to lead key activities to progress YOUR
career, these responsibilities include some of the following:
Compound
Owner Coder/Approver – Contribute actively in study team as coding
representative, acting as primary point of contact for dictionary-related
matters for assigned compounds, diseases or business areas. Interacts with other functional areas to include
Clinical, Clinical Data Management Statistics, Safety, local operating
companies, global resourcing partners and contract research organizations. Obtain study milestones to ensure live study
and closed database conversion milestones are planned, resourced and tracked,
codes are delivered to agreed deadlines with quality reviews of coding and
communicated timelines to relevant staff and management. Review draft (e)CRFs to ensure agreed coding
standards are followed and to agree on any new designs where appropriate. Review draft protocols and advise Clinical
and Statistics staff regarding potential Protocol Violators or excluded
medication groups or classifications.
Provide input into study level Data Validation Specifications involving
dictionary codes. Ensure arrangements
are made for autoencoding internal and external studies including global
resourcing partners, coding and non-coding CROs and other business areas during
study set up. Oversee the routine (daily) coding and approving of coding failures
for active studies within assigned compounds/areas. Act as Coder/Approvers, as required, for
critical workload periods or complex terms, by reviewing coding failures and
applying GSK Coding Philosophies and Term Cleaning Guidelines to resolve the
failures via dictionary updates, term edits or generation and resolution of
queries. Develop expertise in selected
diseases, indications or therapeutic area(s) for which the assigned compounds
are being developed. Assist other
Compound Owners during peak periods or to provide holiday cover as required.
Provide, as needed, a list of clinical dictionary codes and/or terms which
identify related events or drug s for analysis reporting. Be able to recognize current and potentials
system problems. Lead consultation
efforts with other team members, senior staff, programmers and statisticians to
correct systems problems, inefficiencies, etc.
Understand, follow and contribute to development of standard
documentation, such as dictionary SOPs, philosophy guidelines, international
working practices and quality control procedures. Educate co-workers outside the department on
dictionary issues and working practices, by answering questions, providing
explanations to accompany requests and making informal presentations at group
meetings. Work closely with other
Clinical Dictionary staff to ensure open communication, leading to consistency
in dictionary usage and constantly improving processes for the department. Communicate timelines, time constraints, and
possible problems to staff and management.
Training
– Provide training to both in-house and external personnel regarding GSK coding
applications and processes. Direct and
assess the training session content.
Ensure availability of current versions of the training materials. Implement the training with training
solutions. Conduct delegate competency
testing as required, (assess and documents the practical application of
training received by personnel). Provide
coding guidance for vendor personnel assigned to the study (production work)..
Therapeutic
Area Coordinator/Back-up – In addition to the core Compound Owner role,
experienced staff may act as Therapeutic Area (TA) or Business Area (BAA)
Coordinator/Back-up. Effectively manage
study related coding workload including daily checks for failures across the
assigned TA/BA. Ensure TA/BA Team
compliance with Coding policies and practices including the insurance of
acceptable data quality for study data using available tools and reports (e.g.,
QC report, CCR, UTRs, ATR). Track and
maintain study milestone information at study, compound and TA/BA levels. Forecast incoming workload at least 6 months
in advance and determine resource requirements to ensure TA/BA study milestones
are met. Routinely set and communicate
workload priorities to relevant staff and customers. Act as a reference pint for Coding issues to
Coders, Compound Owners, plus other study team members and managers across the
assigned therapeutic area(s). Escalate issue to management as appropriate. Act
as Compound Owner for selected compounds or Bas and help others during peak
workload periods. Act as Coder/Approver,
as required, for critical workload periods or complex terms, by reviewing
coding failures and applying GSK Coding Philosophies and Term Cleaning
Guidelines to resolve the failures via dictionary updates, term edits or
generation and resolution of queries.
Functional
Area Lead/Back-up -In addition to the core.Compound Owner role experienced
staff may act as Lead or Back-up in one or more areas of dictionary expertise
or development. These include: Medical
and/or Drug Dictionary Experts.
We
are looking for an experience individual and if you have these skills, we would
like to speak to you.
Bachelors
or equivalent Science, Life Science, Nursing, Pharmacy or related
medical/clinical area.
Good
understanding of the clinical trial process and where coding fits in the
picture.
Knowledge
in a therapeutic or functional area
Ability
to plan, prioritise and multi-task for studies, compounds, TAs or projects. Uses time efficiently and effectively. Concentrates efforts on the most important
priorities.
Ability
to answer complex autoencoding and failure processing queries. May lead development of standard
skill/tool-based autoencoding and dictionary training across WWD to larger
groups.
Solid interpersonal/soft skills. Coding
colleagues and WWD contacts. Communicate
study and CDDM relate information across WWD.
May give presentations or training across WWD in specific aspects of
coding to small groups. Give and receive
feedback
Able
to work with others within GSK.
Demonstrates
positive, flexible support and partners effectively with colleagues and
stakeholders.
Attend
industry and dictionary related meeting for professional development and
networking and feedback. May represent
GSK in local industry meetings.
May
present or be active member of industry group in area of expertise.
Effective
vendor management and influencing.
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